We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

ForRichard J. Davey, M.D.DirectorDivision of Blood ApplicationsOffice of Blood Research and ReviewCenter for Biologics Evaluation and Research

Enclosure

Indications for Use

510(k) Number:Device Name:

BK110055MediCopia Transfusion

Indications For Use:

MediCopia Transfusion is intended for use in hospitals by healthcare professionals trained in the administration of blood transfusions. MediCopia Transfusion is intended to increase transfusion safety by providing positive patient identification at the bedside at the time of transfusion of blood or blood products. At each stage of the process, the caregiver is given prompts by MediCopia Transfusion, requiring them to scan the patient, blood unit or compatibility label barcodes, enter patient vital signs, confirm special blood requirements, record volume transfused, or indicate transfusion reactions. Each response is recorded in a transfusion record that may be printed for the patient's record.

This software should not be used as the sole method for determining transfusion safety. This software is meant as a clinical aid and requires use by trained professional personnel.